Trial intelligence / Profile preview

TCM Combined with Chemotherapy in Postoperative NSCLC

NCT01441752Phase 3

Key facts

Status: Completed
Start: Nov 2011
Primary completion: Mar 2015
Countries: 1
Sponsor: Xuling Biotech
Modality: HMF (Herbal Medicine Formulation)

Drugs: bazhengsan
Conditions: non-small cell lung cancer (NSCLC)

Overview

Phase 3, randomised, double-blind trial of bazhengsan in non-small cell lung cancer (NSCLC) (2 arms), sponsored by Xuling Biotech. Primary endpoint: Quality of Life. Started Nov 2011; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Chemotherapy + TCM group
Chemotherapy (Vinorelbine + Cisplatin) + TCM granules, followed by TCM maintenance
Chemotherapy + placebo group
Chemotherapy (Vinorelbine + Cisplatin) + Placebo granules, followed by observation

Who it enrols

Patients with pathologically confirmed NSCLC (Stage Ib-IIIb, or Stage Ia > 2cm) who have undergone complete resection and have not yet received adjuvant chemotherapy.

Endpoints

Primary

Quality of Lifeevery 3 weeks

Secondary

2-year Disease-Free Survival Rate2 years
Disease-Free Survivalevery 3 months

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